Sandoz, a Novartis company, has announced that the FDA has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen's US-licensed Enbrel®* (etanercept) - a tumor necrosis factor alpha (TNF-alpha) inhibitor. Sandoz is seeking approval for all indications included in the label of the reference product which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis affecting approx. 1.3 million[1] and 7.5 million[2] people (respectively) in the US.
Mark McCamish, M.D., Ph.D., and Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz said "anti-TNFs will continue to play a leading role in immunology treatment and the acceptance of our regulatory submission by the FDA today is a significant step towards increasing patient access to these life-changing medicines." McCamish continued "we believe we are the first company to receive FDA file acceptance of a biosimilar version of etanercept."
This is the second BLA submission by Sandoz using the 351(k) biosimilar pathway. The BLA consists of a comprehensive data package that includes data from analytical, functional, pre-clinical and clinical studies. Sandoz believes that the two pivotal clinical studies; a pharmacokinetic (PK) study in healthy volunteers (HVs) and a confirmatory safety and efficacy study in patients with chronic plaque-type psoriasis (EGALITY), will provide confirmation of similarity to the reference product established in prior analytical comparability investigations.